close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Search Results for Regulatory Affairs Clinical Research
Job Title. Location Salary Actions

Regulatory Affairs Project Leader

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork . The Regulatory Affairs Project Leader is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Your duties: As the Regulatory Affairs Project Leader, you will serve as a technical expert on Regulatory Affairs matters and will be responsible for providing assistance in the preparation and submission of global regulatory documents with little to no supervision. You may act as a team le...

Location: Cork,
Regulatory Affairs Project Leader
Cork Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed
Regulatory Affairs Manager (EMEA) Roscommon Not Disclosed

Regulatory Affairs Clinical Research Career Profile

Regulatory Affairs Clinical Research


Working in a CRO (Clinical Research Organisation) means working on large projects simultaneously. The regulatory filing for every stage of the clinical trial needs to be looked after for progress on the drug to be made. Below is an example Spec for a Senior role in a CRO:

Key Responsibilities

  • Liaise directly with regulatory bodies such as EMA & National Competent Authorities and you will maintain relations with key contacts
  • Work as part of the EMEA Regulatory team.
  • Evaluate data, review documentation and support/prepare documentation for medicinal products and medicals devices, as appropriate, for all stages of product development i.e. CTA through to life cycle maintenance
  • Maintain an accurate record of the time and direct costs associated with each project for which you are responsible and where appropriate produce status reports.
  • You will support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and you will deal directly with the sponsor and Regulatory Agencies
  • Control all project related documentation either in paper or electronic form.

Skills / Experience

  • Must have 4-5 Yrs in a similar position.
  • Must have a science degree in a related field.
  • Knowledge of European guidelines and be able to review and evaluate CMC, Pre-Clinical and/or Clinical data in compliance with the relevant guidance.
  • Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.